Effects of Transcranial Direct Current Stimulation (tDCS) in the Management of Suicidal Ideation

Last updated: February 7, 2024
Sponsor: Centre Hospitalier Henri Laborit
Overall Status: Active - Recruiting

Phase

N/A

Condition

Suicide

Depression

Treatment

Transcranial direct current stimulation

Clinical Study ID

NCT06009523
2022-A01454-39
  • Ages > 18
  • All Genders

Study Summary

The main objective of this study is to demonstrate that 15 transcranial direct current stimulation (tDCS) sessions of 30 minutes at 2 mA intensity are effective to reduce suicidal ideation

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age over 18 years
  • Written informed consent
  • Diagnosis of recurrent or isolated depressive episode according to DSM IV criteria (A.P.A. 1994).
  • Stable antidepressant treatment for 3 weeks
  • MADRS score ≥ 20
  • SSI score > 3
  • Subject affiliated to a health insurance system
  • Woman with effective contraception and agreeing to maintain it throughout the studyperiod.

Exclusion

Exclusion Criteria:

  • Depression with psychotic features Axis I (DSM IV) co-morbid diagnosis ofschizophrenia, alcohol and/or other substance dependence (or abuse) (lifetime)
  • Patient who has already undergone an electroconvulsive therapy course for the currentepisode and does not respond to this treatment
  • Patient deprived of liberty
  • Patient with high suicide risk (item 10 MADRS > 4) in the absence of hospitalization
  • Contraindication to tDCS: intracerebral metallic implant (with the exception of dentalimplants), cardiac pacemaker, active or non-implanted devices in the region of thehead, acute eczema in the planned stimulation area
  • Pregnant, parturient or breastfeeding woman
  • Simultaneous participation in another interventional research

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Transcranial direct current stimulation
Phase:
Study Start date:
October 26, 2023
Estimated Completion Date:
December 01, 2026

Study Description

After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening visit to determine eligibility for study entry. Patient who meet the eligibility requirements be able to start the 15 tDCS sessions at the rate of one session per day. After the last session, patients will perform three follow-up visits on D19, D49 and D79

Connect with a study center

  • Centre Hospitalier Nord-Deux-Sèvres

    Faye-l'abbesse,
    France

    Active - Recruiting

  • Centre Hospitalier Henri Laborit

    Poitiers,
    France

    Active - Recruiting

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